Skip to main content
Clinical Trials/CTRI/2021/09/036130
CTRI/2021/09/036130Not yet recruitingPhase 2

Prevent cancer Foundation, US-2021 Global cancer Prevention Grant Preventing cervical cancer through low-cost HPV testing approaches in low resource settings of India

Prevent Cancer Foundation3 sites in 1 country300 target enrollmentStarted: October 15, 2021Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
300
Locations
3
Primary Endpoint
Mean change in knowledge, attitude and practice in the community on HPV screening towards cervical cancer.

Study Overview

Brief Summary

Cervical cancer poses a huge public health problem in India with one of the highest rates globally and contributing to one quarter of global burden. Women between 35-65 years of age are at increased risk for developing cervical cancer, especially the rates are high among women from rural, poor areas of the country. The disease has excellent prognosis if diagnosed at an early stage. Screening for cervical cancer is one of the methods for prevention and early diagnosis of the disease. HPV testing on self-collected samples by women is a low-cost screening technique for cervical cancer which may increase the scope of screening among women from rural, tribal and poor and low health literacy communities and improve outcomes. We outline plans to demonstrate a feasible cervical cancer screening in low-health-literacy regions of India - with HPV testing as a primary screening modality, emphasizing role of stakeholders’ engagement and capacity building of organizations that will inform national screening policy. We have chosen 3 areas (rural, urban slum and tribal) for study implementation.

We propose to do it in three stands – First strand, will involve descriptive research and community engagement. We will conduct two workshops in the community inviting community leaders, local govt. officials and key community members. We will also conduct two focus group discussions with women and men groups, in each of the three areas and 10 key informant interviews, in each area to understand awareness, social, cultural, financial and health system barriers and facilitators to the disease and its screening. Second strand, involves educational activities, community participation and screening for cervical cancer. We will educate the community using different educational methods like option grid and puppet shows to improve awareness and acceptance to screening. We will invite the eligible women for participation in screening through self-collected samples and those found positive will be encouraged to visit hospital for further tests and treatment. Third strand, involves evaluation and stakeholder engagement activities. We will conduct semi-structured interviews with community health workers, health care providers and sample of screened women and their husbands; stakeholder workshops will be conducted to disseminate our findings. We will do a survey of 100 men and women from each of the three areas (300 in total) using a questionnaire before and after the intervention to determine change in knowledge, attitude and practice. We will collate the qualitative and quantitative findings and disseminate to policy makers and administrators to inform a national screening policy.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Inclusion criteria.
  • Age 30-60 years Sex.
  • Both males and females.

Exclusion Criteria

  • Exclusion criteria.
  • Unwilling to participate.

Outcomes

Primary Outcomes

Mean change in knowledge, attitude and practice in the community on HPV screening towards cervical cancer.

Time Frame: Oct 2021 to July 2022

Secondary Outcomes

  • To initiate policy decisions on national level scale up of cervical cancer services for poor women in India.

Investigators

Sponsor
Prevent Cancer Foundation
Sponsor Class
Other [Nonprofit Organisation ]

Study Sites (3)

Loading locations...

Similar Trials